Responsibility for a Pharmacovigilance Reporting System

Who in the Company is Responsible for Maintenance of a Pharmacovigilance Reporting System?

The Marketing Authorisation Holder and not the Responsible Person must ensure that a reporting system is in place. For this purpose, they must appoint a Responsible Person PV to fulfil the reporting obligations (cf. Art. 59 (HMG) of the Swiss Medicinal Products Act, Art. 7 (AMBV) of the Swiss Medicinal Products Approval Ordinance).

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Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director

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